HW 7

Go to:


o   Under “Recalls and Alerts”, click on “Warning Letters” o   Under “Ways to View/Browse Warning Letters”, type GLP in the search box. Click on “Search”.

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o   Examine the table showing the “Warning Letters Search Results”.  What are the different centers (3) in the FDA that that issue GLP warning letters?


Go to:


Summarize and comment on specific GLP violations by SNBL in the warning letter (specific actions/activities or lack thereof). 

o   From the first paragraph, the inspections are conducted as part of which FDA program? 

o   Which personnel has “primary responsibility to establish appropriate policies and procedures intended to ensure the quality and integrity of nonclinical safety data for FDA submission”?

o   Within how many business days of the Warning Letter receipt is SNBL supposed to respond to the FDA issues?